Effect of Preoperative Hospitalization Duration on Post-operative Cognitive Dysfunction
1 other identifier
observational
64
0 countries
N/A
Brief Summary
Post-operative cognitive dysfunction is defined as a decrease in cognitive functions which develop following surgery and anesthesia administration that can last up to weeks or even months after surgery. In this study, our main objective was to investigate the effect of preoperative hospitalisation period on early post operative cognitive dysfunction development and its risk factors in patients who underwent total hip replacement surgery for hip fractures under regional anesthesia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2013
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2014
CompletedFirst Submitted
Initial submission to the registry
September 17, 2017
CompletedFirst Posted
Study publicly available on registry
September 25, 2017
CompletedSeptember 25, 2017
September 1, 2017
11 months
September 17, 2017
September 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post operative Cognitive Dysfunction
Mini mental test
change of Mini mental test score from hospitalisation time to post operative 24th hour
Study Arms (2)
No Post operative cognitive dysfunction
Patients who did not have any change or a change less than 4 points between MMT1 and MMT3
Post operative cognitive dysfunction
Patients with a difference more than 4 points between MMT1 and MMT3
Interventions
Mini Mental Test was used for literate patients and Modified mini mental test was used for illiterated patients
Eligibility Criteria
Patients who underwent total hip replacement surgery over 18 aged
You may qualify if:
- Patients who were planned to undergo total hip replacement surgery without cement over 18 years of age and within ASA Group 1, 2 and 3 according to ASA physical status score were included in the study.
You may not qualify if:
- Patients younger than 18, who did not speak Turkish, with known cancer history, previous steroid treatment, SVO history in last 6 months, with central nervous system diseases (current meningitis, encephalitis, tumors, major degenerative diseases), with dementia, Alzheimer's and Parkinson's Disease, pregnant patients, patients with neuropsychiatric diseases or received antidepressant, antipsychotic or anticonvulsive treatment in the last 6 months, uncooperative patients, patients with substance abuse problems, patients with severe organ failure (end-stage liver failure, dialysis-dependent kidney failure), patients who required ICU following surgery, patients where regional anesthesia was contraindicated (Idiopathic intracranial hypertension (IIH), clotting disorders, infection on operational site) were excluded from the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Burcu OZALP HORSANALI
Study Record Dates
First Submitted
September 17, 2017
First Posted
September 25, 2017
Study Start
November 1, 2013
Primary Completion
September 30, 2014
Study Completion
September 30, 2014
Last Updated
September 25, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share